Stroke
Conditions
Keywords
Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke
Brief summary
The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.
Interventions
Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
DEVICECombination of Transcranial direct brain stimulation (tDCS) and FES
Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
Sponsors
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease) * Ability to reach 60 degrees in the shoulder flexion * Minimal cognitive ability to understand commands * No current use of antiepileptic drugs for seizures
Exclusion criteria
* Painful shoulder, adhesive capsulitis or glenohumeral subluxation * Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | 3-D motion analysis system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip force assessed by means of dynamometer | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | Evaluated by means of dynamometer (Jamar) |
| Manual dexterity assessed by means of the block and box test | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | Block and box test |
| Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL) | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | Questionnaire |
| Muscular tone assessed by the Modified Ashworth Scale | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | Modified Ashworth Scale |
| Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale | Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up) | Fugl-Meyer scale |
Countries
Brazil
Outcome results
None listed